(EN) ISO 13485:2016 Medical Device QMS Standard

Put ISO 13485:2016 in your rear-view mirror

We been waiting over a decade for this. It's not that often that I get excited about something, but this one has me standing at attention. My life's work revolves around developing hopefully-lean Quality Management Systems, mostly for small organizations. And now I have a new challenge...

What fun you will have refining your QMS to align with the tweaked elements of the updated standard. After you compare and contrast the 2003 version with the 2016 version your upset stomach may resolve itself --- you may find that you already conform with some if not most of the revised requirements.

As a simple first step, let's compare the numbering and titles for the requirements clauses.

ISO 13485:2003, EN ISO 13485:2012	ISO 13485:2016, EN ISO 13485:2016
4 Quality management system 4.1 General requirements	4 Quality management system 4.1 General requirements
4.2 Documentation requirements 4.2.1 General	4.2 Documentation requirements 4.2.1 General
4.2.2 Quality manual	4.2.2 Quality manual
4.2.3 Control of documents 4.2.4 Control of records	4.2.3 Medical device file 4.2.4 Control of documents 4.2.5 Control of records
5 Management responsibility 5.1 Management commitment	5 Management responsibility 5.1 Management commitment
5.2 Customer focus	5.2 Customer focus
5.3 Quality policy	5.3 Quality policy
5.4 Planning 5.4.1 Quality objectives	5.4 Planning 5.4.1 Quality objectives
5.4.2 Quality management system planning	5.4.2 Quality management system planning
5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority	5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority
5.5.2 Management representative	5.5.2 Management representative
5.5.3 Internal communication	5.5.3 Internal communication
5.6 Management review 5.6.1 General 5.6.2 Review input 5.6.3 Review output	5.6 Management review 5.6.1 General 5.6.2 Review input 5.6.3 Review output
6. Resource management 6.1 Provision of resources	6. Resource management 6.1 Provision of resources
6.2 Human resources 6.2.1 General 6.2.2 Competence, awareness and training	6.2 Human resources 6.2.1 General 6.2.2 Competence, awareness and training
6.3 Infrastructure	6.3 Infrastructure
6.4 Work environment	6.4 Work environment and contamination control 6.4.1 Work environment 6.4.2 Contamination control
7 Product realization 7.1 Planning of product realization	7 Product realization 7.1 Planning of product realization
7.2 Customer-related processes 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.3 Customer communication	7.2 Customer-related processes 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.3 Communication
7.3 Design and development 7.3.1 Design and development planning	7.3 Design and development 7.3.1 General 7.3.2 Design and development planning
7.3.2 Design and development inputs	7.3.3 Design and development inputs
7.3.3 Design and development outputs	7.3.4 Design and development outputs
7.3.4 Design and development review	7.3.5 Design and development review
7.3.5 Design and development verification	7.3.6 Design and development verification
7.3.6 Design and development validation	7.3.7 Design and development validation
	7.3.8 Design transfer
7.3.7 Control of design and development changes	7.3.9 Control of design and development changes
	7.3.10 Design and development files
7.4 Purchasing 7.4.1 Purchasing process	7.4 Purchasing 7.4.1 Purchasing process
7.4.2 Purchasing information	7.4.2 Purchasing information
7.4.3 Verification of purchased product	7.4.3 Verification of purchased product
7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.1.1 General requirements 7.5.1.2 Control of production and service provision - Specific requirements 7.5.1.2.1 Cleanliness of product and contamination control 7.5.1.2.2 Installation activities 7.5.1.2.3 Servicing activities 7.5.1.3 Particular requirements for sterile medical devices 7.5.2 Validation of processes for production and service provision 7.5.2.1 General requirements 7.5.2.2 Particular requirements for sterile medical devices	7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.2 Cleanliness of product 7.5.3 Installation activities 7.5.4 Servicing activities 7.5.5 Particular requirements for sterile medical devices 7.5.6 Validation of processes for production and service provision 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems
7.5.3 Identification and traceability 7.5.3.1 Identification 7.5.3.2 Traceability 7.5.3.2.1 General 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices 7.5.3.3 Status identification	7.5.8 Identification 7.5.9 Traceability
7.5.4 Customer property	7.5.10 Customer property
7.5.5 Preservation of product	7.5.11 Preservation of product
7.6 Control of monitoring and measuring devices	7.6 Control of monitoring and measuring equipment
8 Measurement, analysis and improvement 8.1 General	8 Measurement, analysis and improvement 8.1 General
8.2 Monitoring and measurement 8.2.1 Feedback	8.2 Monitoring and measurement 8.2.1 Feedback 8.2.2 Complaint handling
	8.2.3 Reporting to regulatory authorities
8.2.2 Internal audit	8.2.4 Internal audit
8.2.3 Monitoring and measurement of processes	8.2.5 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product 8.2.4.1 General requirements 8.2.4.2 Particular requirement for active implantable medical devices and implantable medical devices	8.2.6 Monitoring and measurement of product
8.3 Control of nonconforming product	8.3 Control of nonconforming product 8.3.1 General 8.3.2 Actions in response to nonconforming product detected before delivery 8.3.3 Actions in response to nonconforming product detected after delivery 8.3.4 Rework
8.4 Analysis of data	8.4 Analysis of data
8.5 Improvement 8.5.1 General	8.5 Improvement 8.5.1 General
8.5.2 Corrective action 8.5.3 Preventive action	8.5.2 Corrective action 8.5.3 Preventive action

As a more complicated second step, read the 2016 version side-by-side with the 2003 version...and take notes.

Hell...while you are at it, perform a gap analysis to identify which documents in your existing QMS require revision. This is where the real fun begins.

Other Resources:
ISO 9000 Vocabulary changes - Blog post

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